Sterile injectables development and manufacturing

From early-stage formulation through commercial supply, OneSource delivers integrated capabilities for the development and manufacturing of sterile injectable drug products. Our teams combine formulation science, analytical expertise, and scalable manufacturing to support even the most demanding injectable programs.

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End-to-end delivery for Sterile Injectable programs

Injectable products present unique challenges across formulation, manufacturing, and delivery. At OneSource, we address this complexity through a fully integrated model spanning development, manufacturing, and final product assembly.

Rather than treating these as separate workstreams, our teams operate within a unified framework that connects development, analytical, regulatory, and manufacturing activities from the outset. This enables seamless progression across the product lifecycle while reducing risk and accelerating timelines.

End-to-end injectable development and manufacturing services

Lifecycle Stage Core Capabilities Key Outcomes
Pre-Formulation & Feasibility API characterization, excipient screening, compatibility assessment, and feasibility studies Early risk mitigation and a defined formulation development strategy
Formulation Development Liquid and lyophilized formulation design, stability optimization, and high-viscosity formulation support Stable, scalable formulations aligned with the intended delivery format
Analytical Development Method development and validation, stability testing, and microbiological testing Reliable data to support development, scale-up, and regulatory submission
Process Development & Scale-Up QbD-driven development, DoE studies, CPP/CQA identification, and lyophilization cycle development Robust, reproducible, and scalable manufacturing processes
Clinical Manufacturing Small-scale sterile manufacturing, batch execution, and technology transfer Clinical supply readiness with regulatory alignment
Commercial Manufacturing Aseptic fill-finish, lyophilization, inspection, packaging, and serialization Consistent, compliant, and scalable commercial product supply
Device Integration & Assembly Prefilled syringes, cartridges, autoinjectors, and pen-system assembly Patient-ready combination products designed for usability and reliability
Lifecycle Management Technology transfer, validation, process optimization, and ongoing product support Sustained product performance, supply continuity, and lifecycle value

What defines “Sterile Injectables”

At OneSource, complexity is defined not only by sterility requirements but also by the interplay between formulation, delivery, and patient use.

We specialize in injectable products that require advanced formulation strategies, precise process control, and integration with delivery systems. This includes peptides, suspensions, high-viscosity systems, aseptically filled products, lyophilised products, and drug-device-combination products, where performance depends on tight alignment between product and process.

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Injectable Formats and Applications Supported

Format Category Specific Formats Typical Applications Complexity Drivers
Liquid Injectables Small-volume parenterals (vials), prefilled syringes Acute care, chronic therapies Oxygen sensitivity, stability, fill accuracy
Lyophilized Products Lyophilized vials Biologics, peptides, temperature-sensitive APIs Cycle optimization, reconstitution performance
Dry Powder Injectables Dry powder vials Antibiotics, anti-infectives Moisture control, sterility assurance
Advanced Dispersions Emulsions, suspensions, liposomes, nanoparticles Targeted delivery, complex APIs Physical stability, particle distribution
Long-Acting / Depot Systems Implants, depots Sustained-release therapies Release kinetics, formulation complexity
Device-Integrated Formats Cartridges, autoinjectors, pen systems Self-administered therapies (e.g., GLP-1) Device compatibility, dose accuracy, usability

Formulation and process development built for scale

Successful injectable products begin with robust, scalable development.

Our teams apply a Quality by Design (QbD) framework to ensure that products are designed with scalability, stability, and regulatory expectations in mind from the outset. This includes optimizing excipient selection, stability profiles, and key formulation characteristics, particularly for sensitive molecules, complex formulations, and high-viscosity systems.

Process development activities focus on identifying critical quality attributes and process parameters, defining effective control strategies, and preparing each product for efficient scale-up. A key differentiator is our expertise in lyophilization cycle development, where advanced modeling and experimental design are used to optimize cycle times, improve stability, and reduce manufacturing costs.

Precision at every fill: Sterile Injectables Capabilities

Sterile injectables at OneSource are built on an integrated Bangalore platform spanning formulation, lyophilization and isolator-based aseptic filling. Vials, cartridges and pre-filled syringes move through one connected system, backed by 25+ years of domain expertise and 35 approved ANDAs, for consistent, right first time execution from development to commercial scale.

Advanced analytical capabilities supporting development and manufacturing

Analytical rigor is essential to the success of injectable products, particularly for complex and sensitive molecules.

Our capabilities span the full analytical lifecycle:

  • Analytical method development, validation, and transfer
  • Raw material and excipient verification and testing
  • Stability testing under ICH conditions, meeting global stability requirements
  • Peptide and small and large molecule characterization and sameness establishment
  • Cell-based potency assay
  • Receptor SPR binding kinetics
  • Bioactivity confirmation

We support both chemical and microbiological testing, including:

  • Sterility testing and bioburden analysis
  • Endotoxin testing (gel clot and kinetic methods)
  • In-process controls such as fill volume, pH, and density

These capabilities enable consistent product quality from development through commercial manufacturing.

Drug-device integration and patient-centric delivery

A defining capability of OneSource is the integration of drug product development with device selection and assembly.

We support prefilled syringe systems, autoinjectors, and pen-based delivery platforms, enabling patient-friendly, self-administered therapies. We provide device selection and customization, end-to-end development and device assembly customization. We also support services such as finalizing specifications for incoming device components, conducting compatibility studies, validating dose accuracy, and performing full product assembly aligned with final use. By treating both drugs and devices as a single system, we enable more reliable delivery and improved patient outcomes.

Proven success in complex peptide and GLP-1 programs

OneSource’s capabilities in sterile injectables are demonstrated through recent global regulatory milestones supporting generic semaglutide (GLP-1) programs.

Across multiple partnerships, OneSource has supported development, scale-up, and commercial manufacturing for peptide-based injectable products in highly regulated markets.

  • Approval of a generic semaglutide injection in Canada, supporting one of the first entrants in a major global GLP-1 market
  • Health Canada approval for a partner-led semaglutide program, with OneSource providing scale-up and commercial manufacturing
  • Tentative U.S. FDA ANDA approval for a generic semaglutide injection supported through end-to-end CDMO services
  • SFDA approval in Saudi Arabia through a strategic partnership, enabling commercialization across the MENA region

These achievements reflect OneSource’s ability to support global partners in bringing sterile injectable therapies to market.

Resources & Insights

Whitepaper

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The quite revolution in how we take our medicine

The quite revolution in how we take our medicine Ravi Kumar, Global Head of Injectables & Corporate Strategy, Portfolio and SPO Published on Money Control, 05 Jun 2026 Three out of four…

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